科技英語：發(fā)熱嘔吐腦損傷，腦機(jī)人體試驗(yàn)安全性被質(zhì)疑

Neuralink, a company founded by Elon Musk, has encountered technical challenges in its first human trial of a brain implant designed to help paralyzed patients control digital devices through thought.  Neuralink’s brain implant aims to provide paralyzed patients with the ability to operate computers and other digital devices using only their thoughts. The device consists of tiny wires thinner than a human hair, which are implanted in the brain to decode brain signals and translate them into digital actions.
埃隆·馬斯克創(chuàng)立的公司Neuralink在首次進(jìn)行的旨在幫助癱瘓患者通過思維控制數(shù)字設(shè)備的腦植入物人體試驗(yàn)中遇到了技術(shù)挑戰(zhàn)。Neuralink的腦植入物旨在為癱瘓患者提供僅用思維操作電腦和其他數(shù)字設(shè)備的能力。該設(shè)備由比人類頭發(fā)還細(xì)的小電線組成，這些電線植入大腦中以解碼腦信號并將其轉(zhuǎn)化為數(shù)字動作。

In January, Neuralink implanted its device in the brain of its first human patient, Noland Arbaugh, who is paralyzed from the shoulders down due to a 2016 diving accident. The device has enabled Arbaugh to perform digital tasks such as playing video games, browsing the internet, and moving a computer cursor using only his thoughts. Shortly after surgery, Arbaugh surpassed the world record for controlling a cursor with thoughts alone. However, shortly after the surgery, several of the implant’s threads retracted from the brain, resulting in fewer electrodes being able to measure brain signals. Neuralink disclosed this issue last week.
今年一月，Neuralink將其設(shè)備植入了首位人體患者諾蘭·阿爾博（Noland Arbaugh）的腦中。阿爾博因2016年的一次潛水事故導(dǎo)致肩部以下癱瘓。該設(shè)備使阿爾博能夠通過思維進(jìn)行數(shù)字任務(wù)，例如玩電子游戲、瀏覽互聯(lián)網(wǎng)和移動電腦光標(biāo)。手術(shù)后不久，阿爾博超越了僅用思維控制光標(biāo)的世界紀(jì)錄。然而，手術(shù)后不久，植入物的幾根電線從大腦中縮回，導(dǎo)致能夠測量腦信號的電極減少。Neuralink上周披露了這一問題。

The retraction of wires is a problem Neuralink has been aware of for years based on prior animal testing. Despite this, the company assessed the risk as low and did not redesign the device. The retraction results in the loss of sensitive electrodes that decode brain signals, which are crucial for the device’s function.
Neuralink基于此前的動物測試，已經(jīng)意識到電線縮回的問題已有多年。然而，公司評估認(rèn)為風(fēng)險較低，因此并未重新設(shè)計該設(shè)備。電線縮回導(dǎo)致解碼腦信號的敏感電極丟失，而這些電極對設(shè)備的功能至關(guān)重要。

To address the issue, Neuralink made adjustments to the algorithm used by the device to enhance its sensitivity and restore its ability to monitor brain signals. Despite these modifications, the long-term efficacy of this approach remains uncertain. Redesigning the implant’s threads to prevent retraction presents additional risks, such as potential damage to brain tissue if the threads become dislodged or if the device needs to be removed.
為了解決這一問題，Neuralink調(diào)整了設(shè)備使用的算法，以增強(qiáng)其靈敏度并恢復(fù)其監(jiān)測腦信號的能力。盡管進(jìn)行了這些調(diào)整，但這種方法的長期效果仍不確定。重新設(shè)計植入物的電線以防止縮回會帶來額外的風(fēng)險，例如如果電線脫落或設(shè)備需要移除，可能會對腦組織造成損害。

The U.S. Food and Drug Administration (FDA) was informed of the potential issue with the wires through data shared by Neuralink during the application process for human trials. Less than a month after Neuralink announced it was cleared to test its brain implants in humans, FDA inspectors identified problems with record-keeping and quality controls for animal experiments at Neuralink’s California research facility. These inspections, which took place from June 12-22 last year, found lapses such as missing calibration records for instruments and lack of quality assurance sign-off on study reports. However, a similar inspection at Neuralink’s Texas facility did not find problems. Despite the identified issues, the FDA spokesperson Carly Pflaum stated that Neuralink provided sufficient information to support the approval of its human trial application. The agency told Reuters it would continue to monitor the safety of patients enrolled in Neuralink’s study.
美國食品藥品監(jiān)督管理局（FDA）在Neuralink的人體試驗(yàn)申請過程中通過公司共享的數(shù)據(jù)了解到電線可能存在的問題。在Neuralink宣布獲準(zhǔn)在人類進(jìn)行腦植入物測試不到一個月后，F(xiàn)DA檢查人員在去年6月12日至22日對Neuralink加利福尼亞研究設(shè)施進(jìn)行了檢查，發(fā)現(xiàn)記錄保存和動物實(shí)驗(yàn)質(zhì)量控制方面存在問題。這些問題包括儀器的校準(zhǔn)記錄缺失和研究報告缺乏質(zhì)量保證簽字。然而，對Neuralink德克薩斯設(shè)施的類似檢查并未發(fā)現(xiàn)問題。盡管發(fā)現(xiàn)了這些問題，F(xiàn)DA發(fā)言人卡莉·弗勞姆（Carly Pflaum）表示，Neuralink提供了足夠的信息支持其人體試驗(yàn)申請的批準(zhǔn)。該機(jī)構(gòu)告訴路透社，他們將繼續(xù)監(jiān)測Neuralink研究中的患者安全。

During earlier animal tests, some pigs implanted with the device developed brain inflammation called granulomas. This raised safety concerns among Neuralink’s researchers. A subset of pigs developed severe cases, including fever and heaving post-surgery. Neuralink conducted a months-long investigation but could not definitively determine the cause of the granulomas, ultimately concluding that the device and its threads were not to blame.
在早期的動物測試中，一些植入設(shè)備的豬出現(xiàn)了稱為肉芽腫的腦部炎癥。這引起了Neuralink研究人員的安全擔(dān)憂。一部分豬出現(xiàn)了嚴(yán)重的病例，包括術(shù)后發(fā)熱和嘔吐。Neuralink進(jìn)行了為期數(shù)月的調(diào)查，但未能確定肉芽腫的具體原因，最終結(jié)論是設(shè)備及其電線并不是原因。

While the device has demonstrated significant capabilities in enabling paralyzed patients to interact with digital devices, technical issues such as wire retraction and the risk of brain tissue damage need to be addressed. Ongoing monitoring by the FDA and further research will be crucial in ensuring the safety and effectiveness of this innovative technology.
盡管該設(shè)備在使癱瘓患者與數(shù)字設(shè)備互動方面表現(xiàn)出了顯著的能力，但諸如電線縮回和腦組織損傷風(fēng)險等技術(shù)問題仍需解決。FDA的持續(xù)監(jiān)測和進(jìn)一步的研究對于確保這一創(chuàng)新技術(shù)的安全性和有效性至關(guān)重要。